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NCT Number: NCT03357172

Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation

The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location status: Recruiting

Location contact

Marie-Thérèse RUBIO, Pr

CONTACT

0383153030

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient of the Nancy CHRU, for whom a CSH allograft is planned. or
  • hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research

Exclusion criteria

  • Positive HIV
  • active hepatitis B or C infection

Treatment and study plan

Blood sample

Biological

Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2

Bone marrow aspiration

Biological

Additional bone marrow aspiration before graft, D30, D90, Y1

Allogeneic hematopoietic stem cell sample

Biological

Allogeneic hematopoietic stem cell sample

Primary outcomes

  1. Proportions of regulatory immune cells in peripheral blood.

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Secondary outcomes

  1. Occurrence of graft versus host (GVH) reaction after allografting of CSH

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  2. Incidence of relapse

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  3. Incidence of infections

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  4. Progress-free survival

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

  5. Overall survival

    Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Thérèse RUBIO, PU-PH

CONTACT

[email protected]

0383153257 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: REAL-GREFFE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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